Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a controlled clinical trial of 581 subjects aged 3 months to 17 years, adverse reactions occurred at the application site in 6% of subjects treated with VERDESO Foam and 14% of subjects treated with vehicle foam. Other commonly reported adverse reactions for VERDESO Foam and vehicle foam are noted in Table 1.
Table 1: Adverse Reactions in the Clinical Trial
|Adverse Reaction||VERDESO Foam
(N = 387)
(N = 194)
|Upper respiratory tract infection||37 (10%)||12 (6%)|
|Cough||14 (4%)||3 (2%)|
|Application site burning||11 (3%)||15 (8%)|
|Viral infection||6 (2%)||0 (0%)|
|Elevated blood pressure||6 (2%)||1 (1%)|
|Headache||7 (2%)||1 (1%)|
|Asthma||3 (1%)||0 (0%)|
|Irritability||2 (1%)||0 (0%)|
|Pharyngitis||2 (1%)||0 (0%)|
|Application site atrophy||5 (1%)||0 (0%)|
|Application site reactions (including atrophy, striae, telangiectasia, and pigmentation changes)||3 (1%)||6 (3%)|
Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender.
The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post-approval use of VERDESO Foam: application site irritation, application site erythema, application site reactions, skin reactions, and swelling face.